1. Field of Invention
The present invention relates generally to medical methods and apparatus. More particularly, the present invention relates to a method and system for restoring the angle of His and treating and stabilizing hiatal hernias.
Hiatal hernias (also referred to as a hiatus hernia) result when the diaphragm muscle, in particular the diaphragmatic crus, loosens and can no longer firmly hold the esophagus and stomach in their normal position. The esophagus and stomach are able to move in the cranial direction resulting in the stomach being herniated above the diaphragm and into the thoracic cavity. When the hiatal hernia occurs, the esophagus and fundus move upward creating an obtuse angle which facilitates recurrent reflux. The correct configuration at the angle of His is an acute angle which prevents reflux. Hiatal hernias also reposition the lower esophageal sphincter (LES) away from the diaphragmatic crus muscle resulting in a weakening of this structure. Further decrease in LES tone and a shortened LES segment is more likely to result in acid reflux.
A common complication and symptom of hiatal hernia is gastroesophageal reflux disease (GERD). Reflux occurs when the gastroesophageal valve does not close tightly enough or relaxes at the wrong time. Gastroesophageal reflux disease, commonly known as heartburn, acid stomach, or reflux esophagitis, is a common disorder that affects people worldwide. More than 40% of Americans experience typical heartburn on a regular basis, and 10% suffer from heartburn at least once per day. Acid suppressive medication may address occasional or minor GERD; however, reflux often persists despite drug therapy.
Gastroesophageal reflux disease that is untreated over a long period of time can lead to complications, such as esophageal ulcers or perforations. Another common complication is scar tissue that blocks the movement of swallowed food and drink through the esophagus. This condition is called esophageal stricture. Esophageal reflux may also cause less common symptoms, such as hoarseness or chronic cough, and sometimes provokes conditions such as asthma. Overall, at least 19 million American adults experience GERD, making it one of the most common medical conditions. Chronic or severe GERD may cause esophagitis, esophageal stricture and/or Barrett's esophagus.
Medication, open surgical procedures and endoscopic techniques are known for treating GERD. Additionally, and of particular interest to the present invention, a variety of minimally invasive protocols have been developed to treat reflux disease. For example, methods have been developed for creating plications (i.e. folds or tucks) using tissue fasteners in the cardia of the stomach to form a flap of tissue that acts as an anti-reflux valve.
Current minimally invasive treatment protocols suffer from at least three shortcomings. First, creating tissue plications in the cardia of the stomach does not necessarily result in proper reconfiguration of the angle of His or the lower esophageal sphincter which prevents regurgitation of the stomach contents into the esophagus. Second, these plications do not secure the esophagus or stomach or significantly reduce the hiatal hernia. Third, attachment of the tissue fasteners to the tissue of the stomach are unstable and tend to migrate.
For these reasons, it is desirable to provide improved methods and systems for restoring the angle of His and treating hiatal hernias and other conditions by attaching a portion of the lower esophageal wall to the fundus of the stomach and the diaphragmatic crus muscle.
2. Background Art
Minimally invasive methods for treating GERD and related conditions are described, for example, in U.S. Pat. Nos. 7,153,314, 6,835,200, 6,821,285 and 6,773,441 as well as U.S. Patent Application Publication Nos. 2007/0129738, 2007/0112363 and 2007/0088373. Additional U.S. Pat. Nos. 7,232,445, 7,120,498, and U.S. Patent Application Publication Nos. 2007/0142884, 2007/0038232, 2006/0282087, 2006/0015125 and 2005/0277957. Methods to identify internal structures via ultrasound are described in U.S. Pat. Nos. 5,081,993 and 5,993,393, for example.